ObesitySOLFIBERGPNCT06188832
Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms
A study testing glucomannan, inulin, and psyllium in people with Obesity, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial summary
This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- glucomannan, inulin, and psyllium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteRussia
- Study dates
- 2 Mar 2022to 18 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed presence of one or more specified gene polymorphisms (FTO, MC4R, LEP, LEPR).
- Overweight or obese status (BMI ≥ 25).
Who cannot join
- BMI < 25
Trial locations and contacts
1 site in 1 country.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090
About this study
This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Participants were adults aged 18-65 with a BMI ≥ 25 and confirmed genetic predispositions. The study, involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8, and 12 weeks. Primary outcome was Body-weight change in %. The study aimed to clarify the role of fiber supplements in genetically predisposed obese individuals.
- Conditions
- Obesity
- Being tested
- glucomannan, inulin, and psyllium, placebo
- Keywords
- obesity, supplements, body mass index, overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucomannan, inulin, and psylliumDietary supplement
the subjects recieved fiber supplement containing glucomannan, inulin, and psyllium
placeboOther
the subjects recieved placebo
| Study group | Role | What they receive |
|---|---|---|
| Fiber Supplementation | Experimental | The active powder contained 1g glucomannan, 1g inulin, and 3g psyllium per bag. Receives: Dietary Supplement: glucomannan, inulin, and psyllium |
| Placebo group | Placebo comparator | The placebo powder composed of maltodextrin and rice flour, carefully selected to mimic the texture and volume of the active powder without providing any active dietary fiber Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body-weight change in %
Measured: 180 days
Secondary outcomes (16)
body-weight reduction ≥5%
Measured: 180 days
body-weight reduc-tion ≥10%
Measured: 180 days
Body weight in kg
Measured: 180 days
Body mass index change in %
Measured: 180 days
Fat mass change in %
Measured: 180 days
Systolic blood pressure in mmHg
Measured: 180 days
Fat-free mass change in kg
Measured: 180 days
Visceral fat rating change from baseline
Measured: 180 days
Diastolic blood pressure in mmHg
Measured: 180 days
Total cholesterol ratio
Measured: 180 days
LDL-C ratio
Measured: 180 days
HDL-C ratio
Measured: 180 days
Triglycerides ratio
Measured: 180 days
hsCRP ratio
Measured: 180 days
Fasting plasma glucose mmol/l
Measured: 180 days
Side effects %
any side effects or adverse events reported by subjects
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start2 Mar 2022
- Primary completion19 Nov 2022
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center of New Medical Technologies, Triangel Scientific
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188832
- Sponsor's protocol ID
- SW003
- Acronym
- SOLFIBERGP
- Status last verified
- Mar 2025
- First submitted
- 7 Dec 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pokushalov E, Ponomarenko A, Garcia C, Pak I, Shrainer E, Seryakova M, Johnson M, Miller R. The Impact of Glucomannan, Inulin, and Psyllium Supplementation (SolowaysTM) on Weight Loss in Adults with FTO, LEP, LEPR, and MC4R Polymorphisms: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2024 Feb 17;16(4):557. doi: 10.3390/nu16040557.
PubMed 38398881
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms
- ClinicalTrials.gov ID
- NCT06188832
- Acronym / sponsor ID
- SOLFIBERGP / SW003
- Conditions
- Obesity
- Keywords
- obesity, supplements, body mass index, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center of New Medical Technologies, Triangel Scientific
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Participants were adults aged 18-65 with a BMI ≥ 25 and confirmed genetic predispositions. The study, involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8, and 12 weeks. Primary outcome was Body-weight change in %. The study aimed to clarify the role of fiber supplements in genetically predisposed obese individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber Supplementation | Experimental | Dietary Supplement: glucomannan, inulin, and psylliumThe active powder contained 1g glucomannan, 1g inulin, and 3g psyllium per bag. |
| Placebo group | Placebo comparator | Other: placeboThe placebo powder composed of maltodextrin and rice flour, carefully selected to mimic the texture and volume of the active powder without providing any active dietary fiber |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed presence of one or more specified gene polymorphisms (FTO, MC4R, LEP, LEPR).
- Overweight or obese status (BMI ≥ 25).
Key exclusion criteria (1 listed)
- BMI < 25
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucomannan, inulin, and psylliumthe subjects recieved fiber supplement containing glucomannan, inulin, and psyllium | Dietary supplement | Fiber Supplementation |
| placebothe subjects recieved placebo | Other | Placebo group |
Primary outcome
Body-weight change in %
Time frame: 180 days
16 secondary outcomes
body-weight reduction ≥5%
Time frame: 180 days
body-weight reduc-tion ≥10%
Time frame: 180 days
Body weight in kg
Time frame: 180 days
Body mass index change in %
Time frame: 180 days
Fat mass change in %
Time frame: 180 days
Systolic blood pressure in mmHg
Time frame: 180 days
Fat-free mass change in kg
Time frame: 180 days
Visceral fat rating change from baseline
Time frame: 180 days
Diastolic blood pressure in mmHg
Time frame: 180 days
Total cholesterol ratio
Time frame: 180 days
LDL-C ratio
Time frame: 180 days
HDL-C ratio
Time frame: 180 days
Triglycerides ratio
Time frame: 180 days
hsCRP ratio
Time frame: 180 days
Fasting plasma glucose mmol/l
Time frame: 180 days
Side effects %
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Results publication: PubMed 38398881Pokushalov E, Ponomarenko A, Garcia C, Pak I, Shrainer E, Seryakova M, Johnson M, Miller R. The Impact of Glucomannan, Inulin, and Psyllium Supplementation (SolowaysTM) on Weight Loss in Adults with FTO, LEP, LEPR, and MC4R Polymorphisms: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2024 Feb 17;16(4):557. doi: 10.3390/nu16040557.
- 10.3390/nu16040557Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glucomannan, inulin, and psyllium in people with Obesity, run by S.LAB (SOLOWAYS) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body-weight change in % (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.